An observational study in Gastro-enteropancreatic Neuroendocrine Tumor and Acromegaly, sponsored by Ipsen. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Ipsen · Observational
Participants of this study are adults with GEP-NETs and/or acromegaly who were using the Ipsen lanreotide syringe and have transitioned in the last 6 months to the Pharmathen lanreotide syringe, having received at least two injections using the Pharmathen syringe.
GEP-NETs are abnormal growths that develop in the digestive system, including the stomach, intestines, and pancreas. These tumors arise from special cells called neuroendocrine cells, which are found in these organs and release hormones to regulate various bodily functions. GEP-NETs can be slow-growing, and symptoms may vary depending on their location and size.
Acromegaly is a condition where a person's body produces too much growth hormone. This excess hormone can cause certain body parts, like the hands, feet, and face, to enlarge over time. It typically occurs because of a tumor on the pituitary gland in the brain, which is responsible for regulating hormones. Acromegaly can lead to various health issues if not treated, but medications or surgery can often help manage the condition.
Long-acting somatostatin analogs (LA-SSAs) are indicated for patients with Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and acromegaly who are not eligible for surgery or when surgery fails to achieve remission.
Data for this study will be collected after the treatment switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe has occurred, using one round of one-to-one qualitative telephone and/or videoconference interviews with patients. Interviews will last 45 minutes and be carried out in the local language of the participant's country.
The main aim of this study is to capture the patient experience of the Ipsen lanreotide syringe and their experience with the Pharmathen lanreotide syringe.
72 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 24 are open to participants now.
This study's enrollment of 20 is below the median of 164 across 21 observational studies indexed under Gastro-enteropancreatic neuroendocrine tumor.
Browse Gastro-enteropancreatic neuroendocrine tumor studies →Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will include adult patients with GEP-NETs and/or acromegaly living in France, Italy, Spain, UK and the USA
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Qualitative interview: patients' injection experiences and satisfaction with the Ipsen lanreotide syringe and with the Pharmathen lanreotide syringe;
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Qualitative interview: patients' understanding of the reasons for the switch from the Ipsen lanreotide syringe to the Pharmathen lanreotide syringe
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Qualitative interview: patients' perceptions of the Pharmathen lanreotide syringe and of the previous Ipsen lanreotide syringe
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Qualitative interview: patients' preference for the Ipsen lanreotide syringe versus the Pharmathen lanreotide syringe
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients who independently inject
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Qualitative interview: experiences that are unique to patients between disease indications
Interview with a duration of 45 minutes.
Time frame: Up to 6 months after treatment switch
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Access criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Dec 2024, 6 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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